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RINATEC 21MICROGRAMS NASAL SPRAY

Active substance(s): IPRATROPIUM BROMIDE

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Package leaflet: Information for the user

Rinatec® 21micrograms Nasal Spray
(Ipratropium bromide)

Read all of this leaflet carefully before you start
using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets troublesome or
serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Rinatec® 21micrograms
Nasal Spray but will be referred to as Rinatec
throughout this leaflet.
In this leaflet:
1. What Rinatec is and what it is used for
2. Before you use Rinatec
3. How to use Rinatec
4. Possible side effects
5. How to store Rinatec
6. Further information
1.

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using this
medicine if you are pregnant, likely to get pregnant or
are breast-feeding.
Driving and using machines
You may feel dizzy, or have difficulty in focusing, or
blurred vision while taking Rinatec. If this happens do
not drive or use any tools or machines.
Important information about some of the ingredients
of Rinatec
Rinatec contains benzalkonium chloride which is an
irritant to the skin and may cause skin reactions.
3. HOW TO USE RINATEC
Always use Rinatec as your doctor has told you. You
should check with your doctor or pharmacist if you are
not sure.
How many sprays
Adults
Two sprays in each nostril
Two to three times each day

WHAT RINATEC IS AND WHAT IT IS USED FOR

Rinatec is a solution that you spray into your nose.
Rinatec contains a medicine called ipratropium bromide.
This belongs to a group of medicines called
‘anticholinergics’. It is used to help stop a runny nose
caused by Rhinitis. Rhinitis is an inflammation of the
nose which could be because of an allergy (such as hay
fever) or other reasons.
2. BEFORE YOU USE RINATEC
Do not use Rinatec if:
You are allergic (hypersensitive) to ipratropium
bromide or any of the other ingredients in Rinatec
(listed in Section 6 overleaf)
You are allergic (hypersensitive) to medicines that
are similar to Rinatec, such as atropine
Do not use this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before using Rinatec.
Take special care with RINATEC
Check with your doctor or pharmacist before using your
medicine
if:
You have cystic fibrosis
You have glaucoma or any other eye problems
You are a man who has prostate problems
You have problems passing water (urine)
You are pregnant, likely to get pregnant or you are
breast-feeding
If you are not sure if any of the above apply to you, talk
to your
doctor or pharmacist before using Rinatec.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines obtained without a prescription and herbal
medicines. This is because Rinatec can affect the way
some other medicines work. Also some other medicines
can affect the way Rinatec works.

Children under 12 years of age
Rinatec is not recommended for children under 12 years
Using this medicine
1. Remove the cap
2.  The nasal spray pump must be
primed before Rinatec is used for
the first time
 To prime the pump, hold the bottle
with your thumb at the base and
your first and middle fingers on the
white shoulder area. Point the
bottle upright and away from your
eyes. Press your thumb firmly and
quickly against the bottle seven
times. The pump is now primed
and ready to use
 If it has been more than 24 hours
since you used your spray, you
will need to prime the pump again
before using it. Reprime the pump
as before, but this time you will
only need to pump the bottle twice
 If you have not used your spray
for more than seven days you will
need to reprime the pump using
the normal seven sprays
3. Blow your nose to clear your nostrils, if necessary.
4.  Close one nostril by gently placing
your finger against the side of
your nose
 Tilt your head slightly forward
and, keeping the bottle upright,
insert the bottle tip into the other
nostril. Point the tip toward the
back and outer side of your nose
 Press firmly and quickly upwards
with the thumb at the base while
holding the white shoulder area
between your first and middle
fingers



Following each spray, sniff deeply and breathe out
through your mouth. After you have finished
spraying, remove the bottle and tilt your head
backwards for a few seconds to let the spray spread
over the back of the nose
5. Repeat step 4 in the other nostril
6. Replace the cap
7.  If the bottle tip becomes clogged, remove cap.
Hold the bottle tip under warm running water for
about a minute
 Dry the bottle tip, reprime the pump and replace
the cap
If any of the spray accidentally gets into your eyes, wash
it out with cold tap water for several minutes. You may
get painful, stinging or red eyes, dilated pupils, blurred
vision, see colours or lights. If this happens, talk to your
doctor for advice. If affected, do not drive or use any
tools or machines. If you get problems with your eyes at
any other time, talk to your doctor for advice
If you use more Rinatec than you should
Do not use more sprays than the doctor has told you. If
you use more sprays than you should, talk to a doctor or
go to a hospital straight away. Take the medicine pack
with you, even if there is no medicine left.

Rare (affects less than 1 in 1000 people)
Itching or nettle rash (urticaria)
If any of the spray accidentally gets into your eyes, wash
it out with cold tap water for several minutes. You may
get painful, stinging or red eyes, dilated pupils, blurred
vision, see colours or lights. If this happens, talk to your
doctor for advice. If you get problems with your eyes at
any other time, talk to your doctor for advice.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE RINATEC

If you forget to use Rinatec
If you forget a dose, use the spray as soon as you
remember
However, if it is nearly time for the next dose, skip
the missed dose
Do not use a double dose to make up for a forgotten
dose

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and bottle label after ‘Exp’. The
expiry date refers to the last day of the month.
Do not store above 25°C.
Do not expose to excessive heat.
Do not freeze.
Use this spray within six weeks of first priming the nasal
spray pump.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

If you have any further questions on the use of this
product, ask your doctor or pharmacist.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS
Like all medicines, Rinatec can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine:
Stop taking and see a doctor straight away, if you
notice any of the following serious side effects - you
may need urgent medical treatment.
Allergic reactions – the signs may include itching or
nettle rash (affects less than 1 in 1000 people). In
severe cases the signs include swelling of your
mouth and face, skin rash, sudden difficulties in
breathing and reduction of your blood pressure.
Tightening of your throat (affects less than 1 in 100
people)
Increased heart rate, irregular heart rhythm such as
atrial fibrillation or quickening of the heart rate
(affects less than 1 in 100 people)
Palpitations (fast or uneven heart beats) (affects
less than 1 in 1000 people)
Stop using this medicine and see your doctor straight
away if you have any of these side effects.
Other side effects include:
Common (affects less than 1 in 10 people)
Headache or stuffy nose
Nasal drying, nasal irritation such as itching or a
burning sensation or nosebleeds
Throat irritation
Uncommon (affects less than 1 in 100 people)
Skin rash
Dizziness
Unexpected tightness of the chest, swelling of the
throat, dry throat
Blurred vision, difficulty focusing, dilated pupils,
glaucoma, painful, stinging, red or swelling of the
eyes, see colours or lights
Mouth or lip sores
Problems passing water (urine), especially if you
already have problems passing urine
Feeling sick (nausea), stomach upset or discomfort
Dry mouth

What Rinatec contains
The active ingredient is ipratropium bromide.
Each metered dose contains 21micrograms ipratropium
bromide (as monohydrate).
The other ingredients are: sodium chloride,
benzalkonium chloride, disodium edetate, purified water,
sodium hydroxide and hydrochloric acid (for pH
adjustment).
What Rinatec looks like and contents of the pack
Rinatec is a clear, colourless solution, available as a
15ml spray in an amber glass bottle, which gives 180
metered doses.
Manufactured by: Istituto de Angeli S.r.l., Località
Prulli, Reggello (FI), Italy.
Procured from within the EU & repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Rinatec® 21micrograms per metered dose nasal
spray solution – PL No: 18799/2416
Leaflet date: 20.02.2015

POM

Package leaflet: Information for the user

Ipratropium Bromide 21micrograms Nasal Spray Solution
Read all of this leaflet carefully before you start
using this
medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets troublesome or
serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Ipratropium Bromide
21micrograms Nasal Spray Solution but will be referred
to as Ipratropium Bromide throughout this leaflet.
In this leaflet:
1. What Ipratropium Bromide is and what it is used for
2. Before you use Ipratropium Bromide
3. How to use Ipratropium Bromide
4. Possible side effects
5. How to store Ipratropium Bromide
6. Further information
1. WHAT IPRATROPIUM BROMIDE IS AND WHAT
IT IS USED FOR
Ipratropium Bromide is a solution that you spray into
your nose.
Ipratropium Bromide contains a medicine called
ipratropium bromide. This belongs to a group of
medicines called ‘anticholinergics’. It is used to help stop
a runny nose caused by Rhinitis. Rhinitis is an
inflammation of the nose which could be because of an
allergy (such as hay fever) or other reasons.

Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using this
medicine if you are pregnant, likely to get pregnant or
are breast-feeding.
Driving and using machines
You may feel dizzy, or have difficulty in focusing, or
blurred vision while taking Ipratropium Bromide. If this
happens do not drive or use any tools or machines.
Important information about some of the ingredients
of Ipratropium Bromide
Ipratropium Bromide contains benzalkonium chloride
which is an irritant to the skin and may cause skin
reactions.
3. HOW TO USE IPRATROPIUM BROMIDE
Always use Ipratropium Bromide as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
How many sprays
Adults
Two sprays in each nostril
Two to three times each day
Children under 12 years of age
Ipratropium Bromide is not recommended for children
under 12 years
Using this medicine
1. Remove the cap
2. 

2. BEFORE YOU USE IPRATROPIUM BROMIDE
Do not use Ipratropium Bromide if:
You are allergic (hypersensitive) to ipratropium
bromide or any of the other ingredients in
Ipratropium Bromide (listed in Section 6 below)
You are allergic (hypersensitive) to medicines that
are similar to Ipratropium Bromide, such as atropine
Do not use this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before using Ipratropium Bromide.
Take special care with Ipratropium Bromide
Check with your doctor or pharmacist before using your
medicine if:
You have cystic fibrosis
You have glaucoma or any other eye problems
You are a man who has prostate problems
You have problems passing water (urine)
You are pregnant, likely to get pregnant or you are
breast-feeding
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before using Ipratropium
Bromide.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines obtained without a prescription and herbal
medicines. This is because Ipratropium Bromide can
affect the way some other medicines work. Also some
other medicines can affect the way Ipratropium Bromide
works.







The nasal spray pump must be
primed before Ipratropium
Bromide is used for the first time
To prime the pump, hold the bottle
with your thumb at the base and
your first and middle fingers on the
white shoulder area. Point the
bottle upright and away from your
eyes. Press your thumb firmly and
quickly against the bottle seven
times. The pump is now primed
and ready to use
If it has been more than 24 hours
since you used your spray, you
will need to prime the pump again
before using it. Reprime the pump
as before, but this time you will
only need to pump the bottle twice
If you have not used your spray
for more than seven days you will
need to reprime the pump using
the normal seven sprays

3. Blow your nose to clear your nostrils, if necessary.
4. 


Close one nostril by gently placing
your finger against the side of
your nose
Tilt your head slightly forward and,
keeping the bottle upright, insert
the bottle tip into the other nostril.
Point the tip toward the back and
outer side of your nose



Press firmly and quickly upwards with the thumb at
the base while holding the white shoulder area
between your first and middle fingers
 Following each spray, sniff deeply and breathe out
through your mouth. After you have finished
spraying, remove the bottle and tilt your head
backwards for a few seconds to let the spray spread
over the back of the nose
5. Repeat step 4 in the other nostril
6. Replace the cap
7.  If the bottle tip becomes clogged, remove cap.
Hold the bottle tip under warm running water for
about a minute
 Dry the bottle tip, reprime the pump and replace
the cap
If any of the spray accidentally gets into your eyes, wash
it out with cold tap water for several minutes. You may
get painful, stinging or red eyes, dilated pupils, blurred
vision, see colours or lights. If this happens, talk to your
doctor for advice. If affected, do not drive or use any
tools or machines. If you get problems with your eyes at
any other time, talk to your doctor for advice
If you use more Ipratropium Bromide than you
should
Do not use more sprays than the doctor has told you. If
you use more sprays than you should, talk to a doctor or
go to a hospital straight away. Take the medicine pack
with you, even if there is no medicine left.
If you forget to use Ipratropium Bromide
If you forget a dose, use the spray as soon as you
remember
However, if it is nearly time for the next dose, skip
the missed dose
Do not use a double dose to make up for a forgotten
dose
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ipratropium Bromide can cause side
effects, although not everybody gets them. The following
side effects may happen with this medicine:
Stop taking and see a doctor straight away, if you
notice any of the following serious side effects - you
may need urgent medical treatment.
Allergic reactions – the signs may include itching or
nettle rash (affects less than 1 in 1000 people). In
severe cases the signs include swelling of your
mouth and face, skin rash, sudden difficulties in
breathing and reduction of your blood pressure.
Tightening of your throat (affects less than 1 in 100
people)
Increased heart rate, irregular heart rhythm such as
atrial fibrillation or quickening of the heart rate
(affects less than 1 in 100 people)
Palpitations (fast or uneven heart beats) (affects
less than 1 in 1000 people)
Stop using this medicine and see your doctor straight
away if you have any of these side effects.
Other side effects include:
Common (affects less than 1 in 10 people)
Headache or stuffy nose
Nasal drying, nasal irritation such as itching or a
burning sensation or nosebleeds
Throat irritation

Uncommon (affects less than 1 in 100 people)
Skin rash
Dizziness
Unexpected tightness of the chest, swelling of the
throat, dry throat
Blurred vision, difficulty focusing, dilated pupils,
glaucoma, painful, stinging, red or swelling of the
eyes, see colours or lights
Mouth or lip sores
Problems passing water (urine), especially if you
already have problems passing urine
Feeling sick (nausea), stomach upset or discomfort
Dry mouth
Rare (affects less than 1 in 1000 people)
Itching or nettle rash (urticaria)
If any of the spray accidentally gets into your eyes, wash
it out with cold tap water for several minutes. You may
get painful, stinging or red eyes, dilated pupils, blurred
vision, see colours or lights. If this happens, talk to your
doctor for advice. If you get problems with your eyes at
any other time, talk to your doctor for advice.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.
5. HOW TO STORE IPRATROPIUM BROMIDE
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and bottle label after ‘Exp’. The
expiry date refers to the last day of the month.
Do not store above 25°C.
Do not expose to excessive heat.
Do not freeze.
Use this spray within six weeks of first priming the nasal
spray pump.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Ipratropium Bromide contains
The active ingredient is ipratropium bromide.
Each metered dose contains 21micrograms ipratropium
bromide (as monohydrate).
The other ingredients are: sodium chloride,
benzalkonium chloride, disodium edetate, purified water,
sodium hydroxide and hydrochloric acid (for pH
adjustment).
What Ipratropium Bromide looks like and contents
of the pack
Ipratropium Bromide is a clear, colourless solution,
available as a 15ml spray in an amber glass bottle,
which gives 180 metered doses.
Manufactured by: Istituto de Angeli S.r.l., Località
Prulli, Reggello (FI), Italy.
Procured from within the EU & repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Ipratropium Bromide 21micrograms Nasal Spray
Solution – PL No: 18799/2416
Leaflet date: 20.02.2015

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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